Table 2. Results of questionnaires and PPS before and at three months follow up in.
| Statisticalanalyses | Treatment as usual(TAU), baseline(mean, SD) | Treatment as usual(TAU),follow up(mean, SD) | Baseline vs.follow up, P | Active group, baseline(mean, SD) | Active group, follow up(mean, SD) | Baseline vs.follow up, P | 3 month analysisTAU vs. active,P | Effect size | |
| MDI | ITT | 9.40 (6.99) | 8.31 (6.74) | 0.025 | 8.36 (7.70) | 6.48 (6.58) | 0.001 | 0.040 | 0.12 |
| PP | 9.34 (6.21) | 8.32 (6.23) | 7.93 (6.72) | 6.12 (5.35) | |||||
| WHO-5 | ITT | 62.5 (19.0) | 64.8 (20.9) | 0.158 | 66.7 (19.1) | 71.0 (18.3) | 0.015 | 0.016 | 0.11 |
| PP | 63.3 (18.4) | 65.2 (19.2) | 67.2 (19.1) | 71.2 (15.4) | |||||
| PPS | ITT | 80.9 (13.3) | 72.1 (20.5) | <0.001 | 80.8 (13.3) | 58.4 (22.1) | <0.001 | <0.001 | 0.63 |
| PP | 80.6 (13.3) | 71.8 (17.5) | 82.4 (12.3) | 59.7 (20.6) | |||||
| SF-36 physical component summary | ITT | 47.8 (7.68) | 47.7 (9.61) | 0.85 | 48.2 (9.14) | 49.5 (9.99) | 0.04 | 0.14 | 0.14 |
| PP | 47.6 (7.90) | 47.7 (8.56) | 48.8 (8.50) | 50.5 (6.47) | |||||
| SF-36 mental component summary | ITT | 51.9 (9.31) | 53.3 (9.72) | 0.094 | 52.7 (9.35) | 55.3 (9.34) | 0.004 | 0.08 | 0.13 |
| PP | 51.9 (9.23) | 53.3 (6.92) | 53.1 (9.28) | 55.1 (7.84) |
Only statistical analyses using ITT data are presented.
ITT: intention to treat; PP: per protocol; TAU: treatment as usual; MDI: major depression inventory; PPS: pressure pain sensitivity; CSS: Clinical stress signs.